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RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.

The system functionality can be configured based on user needs.

RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.

The system functionality can be configured based on user needs.

RayStation consists of multiple applications:

• The main RayStation application is used for treatment planning.
• The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
• The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.

The device to be marketed, RayStation 2024A SP3, adds the RayTreat application compared with last cleared version, the predicate RayStation 2024A SP3 (without RayTreat), K240398.

The RayTreat application was previously cleared with RayStation 11B, K220141. Since then some RayTreat functions have been changed:

• RayTreat is now session focused
• Usability improvements
• Bug fixes

The RayStation applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data.

As a treatment planning system, RayStation aims to be an extensive software toolbox for generating and evaluating various types of radiotherapy treatment plans. RayStation supports a wide variety of radiotherapy treatment techniques and features an extensive range of tools for manual or semi-automatic treatment planning.

The RayStation applications are divided into modules, which are activated through licensing.

The RayTreat application
RayTreat manages treatment delivery. An approved plan can be assigned to fractions in a treatment course and sent to the treatment delivery device. Treatment records from the treatment delivery device are recorded and sent to RayCarePACS.

Note that all real-time monitoring of actual delivery is handled by treatment delivery device software, not by RayStation.

Scientific concepts that form the basis for the device and significant performance characteristics:

RayStation is a stand-alone software medical device intended for radiation therapy. Input to the device is patient, disease and treatment unit information, output from the device is one or more treatment plans. The treatment plans include treatment unit parameter settings for optimal beam arrangements, energies, field sizes, and ultimately fluence patterns to produce as safe and effective radiation dose distribution as the predicate.

The scientific concepts of a treatment planning system are patient and beam modeling, and algorithms for dose calculation and plan parameter optimization.

The patient model is a computerized representation of the patient tissue and densities, identifying the target regions and particular organs at risk. The model is based on medical images of the patient and must have the desired level of accuracy. Likewise, the beam modeling is a computerized representation of the treatment unit, defined by fluence type, energy distribution, machine specific geometry, and beam modifiers such as MLC, flattening filters, wedges etc. The algorithms for dose calculation and plan parameter optimization must take into account all geometries and materials that affect irradiation transport through the treatment unit and the patient. The optimization algorithm iterates treatment plan parameters until the desired treatment plan and dose distribution have been obtained. Also here, all steps must be done to the desired level of accuracy.

Significant physical characteristics of the device, material used, and physical properties:

The device is a standalone software medical device. It has no physical properties or materials. The device design information can be found in the subsection above "Device design information".

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